Composition containing chlorine dioxide and methods for using same

Abstract

The present invention relates to a composition comprising chlorine dioxide useful in the treatment of active infections of the eye, as well as prophylaxis and treatment of such infections. The invention also relates to uses of compositions including effective amounts of chlorine dioxide in the eye to obtain benefit without detrimentally affecting the eye.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Application No. 62 / 502,085 and U.S. Provisional Application No. 62 / 608,889, each of which is incorporated herein by reference in its entirety.GOVERNMENT INTERESTS[0002]Not applicablePARTIES TO A JOINT RESEARCH AGREEMENT[0003]Not ApplicableINCORPORATION OF MATERIAL ON COMPACT DISC[0004]Not applicableBACKGROUND[0005]Infectious conjunctivitis is an ophthalmic disorder characterized by inflammation of the conjunctiva secondary to invasion by a microbe. Microbes capable of causing conjunctivitis in humans include bacteria (including Mycobacteria), viruses, fungi, or amoebae. Current treatment for bacterial conjunctivitis consists of antibiotic drops. However, ocular surface bacteria are becoming increasingly resistant to available ophthalmic antibiotic eye drops. Because antibiotic drops are ineffective against viral conjunctivitis, treatment of such infections consists only of relieving ...

AI Technical Summary

Benefits of technology

[0010]New uses for chlorine dioxide-containing compositions in the eye have been discovered. Compositions, which include effective amounts of chlorine dioxide, have been found to be ophthalmically acceptable for in-the-eye use. The present invention is easy and straightforward to practice. For example, the invention can be practiced using techniques used in employing prior art ophthalmic antiseptics and ocular surgical irrigants. Little or no additional cost is involved in practicing the present invention relative to using conventional ophthalmic antiseptics and ocular surgical irrigants. The chlorine dioxide-containing compositions useful in the present methods can be formed from stable precursor compositions very shortly (directly) prior to use. Such precursor compositions have relatively long shelf lives, and produce chlorine dioxide-containing compositions having reliable and reproducible chlorine dioxide concentrations which are effective as ophthalmic antiseptics and ocular surgical irrigants, and are ophthalmically acceptable.

[0011]In one broad aspect of the present invention, a composition compnsmg effective amounts of chlorine dioxide are provided that is suitable for topical administration to an eye, effective for treatment and / or prophylaxis of a microorganism infection or a disorder of at least one tissue of the eye. The therapeutic amount of chlorine dioxide in the composition is from about 0.005% (w / w) to about 10% (w / w). Such compositions are particularly effective where the eye has a microbial infection, such as bacterial conjunctivitis and / or other microbial infection, since it is effective in treating, preferably reducing or even eliminating, the microbial infection. The presently useful compositions preferably have a pH in the range of about 5 to about 10, are substantially isotonic, or a combination thereof.

Problems solved by technology

However, ocular surface bacteria are becoming increasingly resistant to available ophthalmic antibiotic eye drops.

Because antibiotic drops are ineffective against viral conjunctivitis, treatment of such infections consists only of relieving symptoms or preventing secondary bacterial infection.

Diagnosis of the various causative agents such as bacteria, virus, or fungus, in infectious conjunctivitis is not economically feasible because accurate diagnosis requires sophisticated laboratory culture equipment not easily integrated into the average healthcare practice.

In addition, culture results for bacterial conjunctivitis are often inconclusive because the bacteria cultured are often those that are part of the normal ocular surface flora.

Viral cultures are impractical because of the length of time needed for culture results to be obtained which often exceed the period of infection.

Because accurate diagnosis is impractical and because there are no approved treatments for viral conjunctivitis, most conjunctivitis is presumed to be bacterial without culturing and is treated with antibiotics.

Antibiotic treatment is suboptimal because it is ineffective against viral or fungal conjunctivitis and contributes to the development of bacterial resistance.

Viral conjunctivitis caused by adenovirus is extremely contagious and can lead to wide spread infection in medical offices, work place environments and households.

There is currently no ophthalmic antimicrobial drug with broad spectrum activity against all the causes of conjunctivitis, and there is currently no approved antimicrobial / steroid, or antimicrobial / non-steroidal anti-inflammatory combination drug that has shown to be effective against and to be safely used in infectious conjunctivitis that is viral or fungal in origin.